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EC number: 211-995-8 | CAS number: 734-32-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 26 Feb. 1987
- Deviations:
- yes
- Remarks:
- 4 instead of 3 animals
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Estr-4-ene-3,17-dione
- EC Number:
- 211-995-8
- EC Name:
- Estr-4-ene-3,17-dione
- Cas Number:
- 734-32-7
- Molecular formula:
- C18H24O2
- IUPAC Name:
- estr-4-ene-3,17-dione
- Test material form:
- other: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Schriever
- Weight at study initiation: males: 3.0 kg, females: 2.8 - 3.1 kg
- Housing: 1/cage
- Diet (e.g. ad libitum): pell. Altromin® K, ad libitum
- Water (e.g. ad libitum): demineralized water, ad libitum
- Acclimation period: > 14 days; during this period a diet containing 0.03% sulfaquinoxaline was offered for 7 consecutive days as coccidiosis prophylaxis; the animals received Jacutin® emulsion into the meatus acusticus exterilljg for prophylaxis
against mite infection of the ear and were vaccinated against rabbit haemorrhagic disease (Arvilap®)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22°C
- Humidity (%): 66 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed)
- Observation period (in vivo):
- 6 days
- Number of animals or in vitro replicates:
- 2 males, 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Animal no. 605F was sacrificed on day 3 of the study for humane reasons since it suffered from a paresis of the hind legs due to dislocation of sacral vertebra. This animal was without findings from day 2 onwards.
Any other information on results incl. tables
Table 1: Results of the study
Irritant effects (score) | |||||
Animal no. (sex) | Irritation parameter | 24 h | 48 h | 72 h | Mean scores |
1 (M) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 0 | 0 | 0 | 0.0 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
2 (M) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 2 | 0 | 0 | 0.7 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
3 (F) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 0 | 0 | 0 | 0.0 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
4 (F) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 2 | 0 | 0 | 0.7 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0 |
The control eyes were without findings.
Findings after treatment with the test substance were slight to severe secretion, slight to moderate reddening and swelling of the outer eye lids and eye lid closure on the application day. Furthermore, slight to mainly moderate reddening and swelling of the conjunctivae and slight to moderate injection of blood vessels were observed. Additionally, in one animal moderate reddening of the iris was noted 1 and 2 hours after application. On day 2, 2 animals still showed slight to moderate reddening and vascular injection of the conjunctivae. From day 2 or 3 onwards, all animals were without findings.
Applicant's summary and conclusion
- Conclusions:
- In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked transient mainly moderate signs of irritation. The findings were fully reversible by day 3 after administration. According to EU classification criteria need not be labelled as an eye irritant.
- Executive summary:
In an eye irritation study according to OECD Guideline 405, four New Zealand White rabbits (2M, 2F) each received a volume of 0.1 ml Norandrostenedione (corresponding to 60.1 - 64.0 mg substance) into the conjunctival sac of the right eye. The left eye remained untreated and served as control.
During application and observation on the application day (first day of the test) the animals were kept in restraining cages for approximately 2.5 hours. No food or water was available during this time. Conjunctivae, eyelids, cornea and iris were evaluated before application, 0.5, 1 and 2 hours thereafter, and then once daily until termination of the study on day 4.
Findings after treatment with the test substance were slight to severe secretion, slight to moderate reddening and swelling of the outer eye lids and eye lid closure on the application day. Furthermore, slight to mainly moderate reddening and swelling of the conjunctivae and slight to moderate injection of blood vessels were observed. Additionally, in one animal moderate reddening of the iris was noted 1 and 2 hours after application. On day 2, 2 animals still showed slight to moderate reddening and vascular injection of the conjunctivae. From day 2 or 3 onwards, all animals were without findings.
According to EU classification criteria need not be labelled as an eye irritant.
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